UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010925 |
|---|---|
| Receipt number | R000012738 |
| Scientific Title | Sarcopenia, Malnutrition in the Geriatric Patient With Oral Cavity Dysfunction |
| Date of disclosure of the study information | 2013/06/17 |
| Last modified on | 2015/01/12 11:28:58 |
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Basic information
Public title
Sarcopenia, Malnutrition in the Geriatric Patient With Oral Cavity Dysfunction
Acronym
Oral Cavity Dysfunction and Sarcopenia
Scientific Title
Sarcopenia, Malnutrition in the Geriatric Patient With Oral Cavity Dysfunction
Scientific Title:Acronym
Oral Cavity Dysfunction and Sarcopenia
Region
| Japan |
Condition
Condition
Oral cavity dysfunction
Classification by specialty
| Geriatrics | Rehabilitation medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the relationship between oral cavity function and sarcopenia of skeletal muscle
Basic objectives2
Others
Basic objectives -Others
Incidence
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle mass of skeletal muscle
Key secondary outcomes
1. Revised Oral Assessment Guide (ROAG)
2. muscle strengh
3. nutritional state
4. activities of daily living
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hospitalized elderly patients under dental treatment
Key exclusion criteria
Patients with edema
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuri Tsuji / Yoshihiro Yoshimura |
Organization
Kumamoto Rehabilitation Hospital
Division name
Dental Surgery / Physical Medicine and Rehabilitation
Zip code
Address
760 Magate, Kikuyo-machi, Kikuchi-gun, Kumamoto
TEL
096-232-3111
hanley.belfus@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Yoshimura |
Organization
Kumamoto Rehabilitation Hospital
Division name
Physical Medicine and Rehabilitation
Zip code
Address
760 Magate, Kikuyo-machi, Kikuchi-gun, Kumamoto
TEL
096-232-3111
Homepage URL
hanley.belfus@gmail.com
Sponsor or person
Institute
Kumamoto Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Rehabilitation Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
熊本リハビリテーション病院(熊本県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Prospective observational study
2. To evaluate the relationship between oral cavity function and sarcopenia of skeletal muscle
3. To evaluate the efficacy of Revised Oral Assessment Guide (ROAG) score as oral cavity assessment
Management information
Registered date
| 2013 | Year | 06 | Month | 11 | Day |
Last modified on
| 2015 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012738
